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SteriChek™ Total Chlorine Test Kit provides a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The water sample changes color relative to the amount of total chlorine in the water sample.

The device consists of utilizing a fixed sample size of powdered reagent with a predetermined water sample volume in a test tube to effect a color reaction in the water sample. The color of the sample is then visually compared to a colormetric comparator to determine the total chlorine level in the sample. The device utilizes a recognized standard method of analysis for determining levels of total chlorine in water according to the Association for the Advancement of Medical Instrumentation (1993 Association for the Advancement of Medical Instrumentation-ANSI/AAMI;RD5-1992).

The provided text describes a medical device, the SteriChek™ Total Chlorine Test Kit, and its 510(k) submission for market clearance. However, the document primarily focuses on the device's description, intended use, and a comparison of its performance to a predicate device. It does not explicitly state specific acceptance criteria (performance targets/thresholds) or a detailed study plan that demonstrates the device meets those criteria.

Instead, it states that the "Performance of both devices was equivalent," referring to the SteriChek™ kit and its predicate device (Serim™ HiSense Test Strips). This implies that the acceptance criteria for the SteriChek™ kit were to show performance equivalent to the legally marketed predicate device.

Therefore, many of the requested details about the study are not explicitly available or are not applicable in the typical sense for a substantial equivalence submission relying on a predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "water samples in which either sodium hypochlorite or monochloramines were added to give a range of free chlorine or combined chlorine levels." The number of these samples is not provided.
• Data Provenance: Not explicitly stated, but the submission is from Environmental Test Systems, Inc. in Elkhart, IN, USA. It's likely the testing was conducted in the USA, but this is not explicitly confirmed. The study appears to be prospective in the sense that the SteriChek™ kit was analyzed with new samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: Not mentioned. The device involves visual comparison to a colorimetric comparator. It's possible that a single operator/technician compared the colors, but details are not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No. This device is a chemical test kit, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI-related effect sizes are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Standalone Performance: The device itself is a "standalone" chemical test kit. Its performance is based on the chemical reaction and visual comparison, not an algorithm. The description implies human-in-the-loop for visual comparison, as the color of the sample is "visually compared to a colormetric comparator."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: The ground truth was established by adding known concentrations of "sodium hypochlorite or monochloramines" to water samples. This creates a synthetic but precisely known (reference) concentration of free or combined chlorine, against which the device's readings are compared.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. The device is a chemical test kit, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

Summary of the Study:

The study performed was a comparison study where the SteriChek™ Total Chlorine Test Kit was evaluated against a predicate device, Serim™ HiSense Test Strips. Both devices were tested with water samples prepared with known concentrations of either sodium hypochlorite (for free chlorine) or monochloramines (for combined chlorine). The objective was to demonstrate that the SteriChek™ kit's performance was "equivalent" to the predicate device. Details on the specific number of samples, how the comparison was quantified (e.g., specific accuracy metrics), or who performed the readings are not provided in this summary. The ground truth was based on the precisely prepared known concentrations of chlorine in the water samples.

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